CervoMed reports last patient last visit in Phase 2b RewinD-LB trial

CervoMed announced the Last Patient Last Visit in RewinD-LB, a Phase 2b clinical trial evaluating neflamapimod in patients with early-stage dementia with Lewy bodies. CervoMed remains on track to report topline efficacy and safety data in December 2024. “Completion of the last patient visit in the RewinD-LB Phase 2b trial is an important milestone in our neflamapimod program for DLB,” said John Alam, MD, CEO of CervoMed. “There has been a high level of enthusiasm from the clinical sites, trial investigators, and patients, reflecting the significant unmet need in the DLB patient population for which no treatment is currently approved. We are also encouraged by the fact that 96% of the patients enrolled into the study completed the 16-week double-blind placebo-controlled portion of the study, of which 98% continued into the open label extension. Furthermore, our independent Data Safety Monitoring Board recently met to conduct a pre-specified review of the available safety data and concluded that the study may proceed without modification. We look forward to sharing topline data in December 2024 We are also pleased to deliver late-breaking oral presentations at the upcoming Clinical Trials on Alzheimer’s Disease conference, where we will discuss plasma biomarker data and their relevance to our ongoing trial. Leveraging insights from our Phase 2a trial and the baseline characteristics of patients enrolled in RewinD-LB, we think that we have enrolled the appropriate early DLB patient population we were targeting when we designed the study, namely participants who both have substantial clinical deficits and are still able to show improvements in their underlying disease process. Combined with the use of a clinically meaningful primary endpoint, these data further increase our confidence that we are well positioned in the trial as we approach the topline readout in December. With a positive result, we believe we’ll have demonstrated true clinical proof-of-concept for neflamapimod as a specific treatment for patients with DLB.”